Actively Recruiting
A Prospective, Single Arm, Open-label Study to Evaluate Accuracy and Precision of CareSens Air 3 Continuous Glucose Monitoring in Adults With Type 1 Diabetes
Led by i-SENS, Inc. · Updated on 2026-04-09
32
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
I
i-SENS, Inc.
Lead Sponsor
I
Integrated Medical Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy and precision of the CareSens Air 3 continuous glucose monitoring (CGM) system in adults with type 1 diabetes. This open-label, single-arm pilot study focuses on adult patients aged 18 to 65 who use intensive insulin therapy. The study aims to provide detailed data on how well this CGM system measures glucose levels compared to a reference device, helping to understand its performance in real-world use. Participants will wear two CareSens Air 3 devices at different insertion sites and one Libre 3 Plus device for 16 days. During this period, they will not have access to glucose readings from the CareSens Air 3 devices. They will continue their usual diabetes treatment and perform at least eight daily finger-stick blood glucose tests using a self-monitoring blood glucose (SMBG) system. The study includes four clinic visits for glucose measurements under carefully controlled conditions, including testing during low and high blood sugar levels. Throughout the 16-day study, participants will be monitored through frequent blood tests and controlled glucose assessments in the clinic. Researchers will measure the accuracy and precision of glucose concentration readings from the CareSens Air 3 devices compared to reference glucose levels. This includes tracking participants’ blood glucose regularly and ensuring safety. The trial will last from the start of device insertion through removal after 16 days, with ongoing observation during clinic visits.
CONDITIONS
Brief Title
Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults who are 18-65 years of age, inclusive
- Diagnosis of type 1 diabetes
- Use of intensive insulin therapy with multiple daily injections or insulin pump, including those using CGM-driven insulin adjustment systems for at least 3 months
- Voluntary participation with written informed consent
You will not qualify if you...
- Severe skin conditions or abnormalities at CGM sensor sites such as severe psoriasis, burns, eczema, scars, extensive tattoos, severe rash, or infections
- Allergic contact dermatitis to medical adhesives
- History of frequent catheter abscesses related to pump therapy
- Severe hypoglycemia events within 3 months prior to screening
- Hypoglycemia unawareness
- Conditions increasing hypoglycemia risk including untreated thyroid or adrenal disease
- Diabetic ketoacidosis within 3 months prior to screening
- History of epilepsy or syncope within 6 months prior to screening
- Unstable or insufficiently treated vascular diseases including stroke, ischemic heart disease, peripheral vascular disease, and serious arrhythmia
- Anemia with hemoglobin below normal range
- Scheduled for X-ray, MRI, CT, or diathermy during the study
- Pregnant, lactating, planning pregnancy, or unwilling to use contraception
- Participation in another clinical study within 2 weeks prior to screening
- Unwillingness to avoid certain foodstuffs beyond allowed amounts
- Cognitive impairment or unsuitable condition for study participation
- Use of pacemaker or similar medical devices
- HbA1c greater than 9.5%
- Dependency on sponsor or investigator
- Inability or unwillingness to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 16 days
Participants will have two CareSens Air 3 devices inserted and will wear them along with one Libre 3 Plus device for 16 days without access to glucose values from the CareSens Air 3 devices while continuing their usual diabetes treatment.
4 visits (in-person) during device use for glucose measurement under controlled conditions
Duration - 16 days
Participants will perform capillary blood glucose measurements at least 8 times daily using the SMBG system throughout the device wear period.
Daily self-monitoring at least 8 times per day
Trial Site Locations
Total: 4 locations
1
Headlands Research AMCR
Escondido, California, United States, 92025
Not Yet Recruiting
2
Diablo Clinical Research
Walnut Creek, California, United States, 94598
Actively Recruiting
3
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
Not Yet Recruiting
4
Rainier Clinical Reseach Center
Renton, Washington, United States, 98057
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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